Simon Davies1, Börje Haraldsson2, François Vrtovsnik3, Vedat Schwenger4, Stanley Fan5, Alexandre Klein6, Saynab Atiye7, Adelheid Gauly7. 1. Faculty of Medicine and Health Sciences, Keele University, Staffordshire, UK. 2. Department of Physiology, University of Gothenburg, Sweden. 3. Department of Nephrology, Xavier Bichat Hospital, Paris, France. 4. Department of Nephrology, Katharinenhospital, Stuttgart, Germany. 5. Department of Nephrology, The Royal London Hospital, London, UK. 6. Department of Nephrology, Hospital Louis Pasteur, Colmar, France. 7. Fresenius Medical Care, Bad Homburg, Germany.
Abstract
BACKGROUND: Patients on peritoneal dialysis (PD) may suffer from sodium (Na) and fluid overload, hypertension and increased cardiovascular risk. Low-Na dialysis solution, by increasing the diffusive removal of Na, might improve blood pressure (BP) management. METHODS: A glucose-compensated, low-Na PD solution (112 mmol/L Na and 2% glucose) was compared to a standard-Na solution (133 mmol/L Na and 1.5% glucose) in a prospective, randomised, single-blind study in hypertensive patients on PD. One daily exchange of the standard dialysis regimen was substituted by either of the study solutions for 6 months. The primary outcome (response) was defined as either a decrease of 24-h systolic BP (SBP) by ≥6 mmHg or a fall in BP requiring a medical intervention (e.g. a reduction of antihypertensive medication) at 8 weeks. RESULTS:One hundred twenty-three patients were assessed for efficacy. Response criteria were achieved in 34.5% and 29.1% of patients using low- and standard-Na solutions, respectively (p = 0.51). Small reductions in 24 h, office, and self-measured BP were observed, more marked with low-Na than with standard-Na solution, but only the between-group difference for self-measured SBP and diastolic BP was significant (p = 0.002 and p = 0.003). Total body water decreased in the low-Na group and increased in the control group, but between-group differences were not significant. Hypotension and dizziness occurred in 27.0% and in 11.1% of patients in the low-Na group and in 16.9% and 4.6% in the control group, respectively. CONCLUSIONS: Superiority of low-Na PD solution over standard-Na solution for control of BP could not be shown. The once daily use of a low-Na PD solution was associated with more hypotensive episodes, suggesting the need to reassess the overall concept of how Na-reduced solutions might be incorporated within the treatment schedule.
RCT Entities:
BACKGROUND:Patients on peritoneal dialysis (PD) may suffer from sodium (Na) and fluid overload, hypertension and increased cardiovascular risk. Low-Na dialysis solution, by increasing the diffusive removal of Na, might improve blood pressure (BP) management. METHODS: A glucose-compensated, low-Na PD solution (112 mmol/L Na and 2% glucose) was compared to a standard-Na solution (133 mmol/L Na and 1.5% glucose) in a prospective, randomised, single-blind study in hypertensivepatients on PD. One daily exchange of the standard dialysis regimen was substituted by either of the study solutions for 6 months. The primary outcome (response) was defined as either a decrease of 24-h systolic BP (SBP) by ≥6 mmHg or a fall in BP requiring a medical intervention (e.g. a reduction of antihypertensive medication) at 8 weeks. RESULTS: One hundred twenty-three patients were assessed for efficacy. Response criteria were achieved in 34.5% and 29.1% of patients using low- and standard-Na solutions, respectively (p = 0.51). Small reductions in 24 h, office, and self-measured BP were observed, more marked with low-Na than with standard-Na solution, but only the between-group difference for self-measured SBP and diastolic BP was significant (p = 0.002 and p = 0.003). Total body water decreased in the low-Na group and increased in the control group, but between-group differences were not significant. Hypotension and dizziness occurred in 27.0% and in 11.1% of patients in the low-Na group and in 16.9% and 4.6% in the control group, respectively. CONCLUSIONS: Superiority of low-Na PD solution over standard-Na solution for control of BP could not be shown. The once daily use of a low-Na PD solution was associated with more hypotensive episodes, suggesting the need to reassess the overall concept of how Na-reduced solutions might be incorporated within the treatment schedule.